Immuno-oncology

The drug maker announced positive topline Phase III results for its subcutaneous PD-1 inhibitor sasanlimab in first-line, BCG-naïve non-muscle invasive bladder cancer combined with BCG.

Five months after taking over the dual-masked T-cell engagers from Sanofi amid a restructuring, the company posted promising initial Phase I data from its PSMA- and HER2-targeting IO candidates.

Galapagos and Gilead are calling time on their ill-fated licensing deal and the Belgian biotech is looking to unlock value by creating a business development-focused spin-out armed with a €2.45bn cash pile. Major job cuts are also on the cards.

Topline Phase III results in EGFR exon 19 deletion/L858R substitution mutation NSCLC indicate more than a year in overall survival improvement over Tagrisso, the current standard of care.

While quieter than some recent years, 2024 did produce several clinical trial readouts destined to have an impact on their respective markets. Here, in roughly chronological order, Scrip takes a look at the 10 clinical stories that got readers clicking the most over the past 12 months.

The new year has already brought multiple deals for China-originated antibody-drug conjugates in the DLL3 class, which companies in the country dominate.

The partners have decided to voluntarily withdraw their EU marketing application for datopotamab deruxtecan in lung cancer, based on regulator feedback, a month after a similar move in the US.

CytoCares’ CEO shares plans for CC312, a potentially first-in-class trispecific antibody for autoimmune disorders it sees as differentiated from global rivals.

After investing heavily in both mechanisms for IO-IO combinations, Merck is cutting its losses with vibostolimab and favezelimab, and switching its anticancer bets to other modalities.

Expert panelists discuss regulatory challenges, flexible approaches to assay selection, and applying scientific reasoning with guidelines to address immunogenicity and safety assessment challenges in oncology biologics and biosimilars.

The biotech’s lead candidate now looks approvable as the first new localized prostate cancer treatment in 20 years – allowing Candel to raise much-needed funds – but a filing must wait

The Chinese company is building on its success with ivonescimab and believes it can stay ahead of its rivals and develop into a global company.

The SKYSCRAPER-01 trial’s failure to generate an overall survival benefit is the biggest blow yet to the TIGIT inhibitor class, but Roche looking to move on with its buyout of the CAR-T therapy company.

The new formulation is expected to play a role in helping Merck maintain its multibillion-dollar cancer franchise after Keytruda loses exclusivity in 2028.

Dosing eftilagimod alpha on top of Merck & Co’s blockbuster appears to improve survival, though more robust data are needed.

The company will in-license LM-299, gaining a PD-1/VEGF bispecific antibody that could help it defend its blockbuster PD-1 franchise against looming competition.

The German group is doubling down on the hot PD-(L)1 x VEGF-A bispecific space but will still have to contend with Summit and Akeso’s more advanced rival.

The exact causes leading to Chinese authorities’ investigation of the UK major remain unclear at this point, but its key oncology drugs are facing fierce local competition from homegrown rivals.

Panels at the recent BioFuture conference focused on the next breakthroughs in areas such as oncology and neurodegenerative diseases, continuing challenges to GLP-1 agonists, financing and how use of AI is taking shape.

Troubled GlycoMimetics will merge with Crescent, bringing its PD-1- and VEGF-targeting bispecific CR-001 and gaining a public listing. Crescent also will raise $200m to help position itself against PD-1xVEGF leaders Akeso/Summit and BioNTech.